欧盟一般食品法Regulation (EC) No 852-2004中文翻译.doc

852.2004法規翻譯CORRIGENDACorrigendum to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs(Official Journal of the European Union L 139 of 30 April 2004)歐洲議會和歐盟理事會2004年4月29日關於食品衛生規章852/2004的修正Regulation (EC) No 852/2004 should read as follows: REGULATION (EC) No 852/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004on the hygiene of foodstuffs一、 法規摘要重點：主要協調歐盟各會員國之食品衛生法，以確保食品在各階段生產過程之衛生標準。規範所有食品企業經營業者(包括食品運輸業者及倉儲業者)須確保遵守食品衛生規範，應符合本法附件一第A部分之一般衛生規範，並要求所有食品業者(不包括原物料生產者)須遵守附件二之一般衛生規範，如食品衛生證明、運輸條件、生產設備、廢棄物處理、水質供應、人員衛生、包裝、食品之加熱處理及食品加工人員之培訓等。此外，該規定第5條亦要求食品業者(除原物料初級產品之生產者外)均須採用食品衛生法規執委會(Codex Alimentarius)所頒布之危害分析重要管制點系統(Hazard Analysis and Critical Control Points, HACCP)之原則及相關要求規定，以確保食品衛生安全。THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Articles 95 and 152(4)(b) thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Economic and Social Committee (2), Having consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), 依第251條制定程序，本法重點：1、 企業經營者應承擔食品安全的主要責任 。2、 應從食品的初级生產開始確保食品生產、加工和銷售之整體食品安全 。3、 全面推行危害分析重要管制點系統(HACCP)。4、 建立食品微生物標準與食品溫度管制之要求 。確保進口食品符合歐洲標準或與其等效之標準。Whereas: 鑑於 (1) The pursuit of a high level of protection of human life and health is one of the fundamental objectives of food law, as laid down in Regulation (EC) No 178/2002 (4). That Regulation also lays down other common principles and definitions for national and Community food law, including the aim of achieving free movement of food within the Community. (1) 食品法律的基本目標之一為追求人類的生命和健康的最高保護，如1993年6月14日公告之規章(EC) No 178/2002擬訂食品衛生的一般原則。此規章也擬訂其他國家和社區的食品法律的一般原則及定義，包括達成食品於歐盟區域內自由流通的目標。(2) Council Directive 93/43/EEC of 14 June 1993 on the hygiene of foodstuffs (5) laid down the general rules of hygiene for foodstuffs and the procedures for verification of compliance with these rules. (2) 1993年6月14日的委員會指令93/43/EEC在食品衛生擬訂了食品的一般衛生規則，和確認符合該法的程序。(3) Experience has shown that these rules and procedures constitute a sound basis for ensuring food safety. In the context of the common agricultural policy, many directives have been adopted to establish specific health rules for the production and placing on the market of the products listed in Annex I to the Treaty. These health rules have reduced trade barriers for the products concerned, contributing to the creation of the internal market while ensuring a high level of protection of public health. (3) 經驗顯示這些規則及程序構成確認食品安全的健全基礎。在一般農業政策內，許多指令已被採取以建立在產品製造和上市的特定衛生規則，這些規則列在條約的附件 I。這些衛生規定降低了相關產品的貿易障礙，在高度保護公共衛生的同時也創造了內部市場。(4) With regard to public health, these rules and procedures contain common principles, in particular in relation to the manufacturers and competent authorities responsibilities, structural, operational and hygiene requirements for establishments, procedures for the approval of establishments, requirements for storage and transport and health marks. (4) 關於公共衛生，這些規定和程序包括一般的原則，特別是關於製造廠商和權責機關的責任、結構、操作和廠場的衛生要求、認可的程序，以及倉儲、運輸與衛生標誌的要求。(5) These principles constitute a common basis for the hygienic production of all food, including products of animal origin listed in Annex I to the Treaty. (5) 這些原則組成所有食品衛生生產的一般基礎，包括條約內附錄I所列的動物性產品。(6) In addition to this common basis, specific hygiene rules are necessary for certain foodstuffs. Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (6) lays down these rules. (6) 除了這項一般的基礎之外，明確的衛生規章對某些產品為必需的。委員會於2004年4月29日之歐洲國會規章(EC) No 853/2004 擬訂具體的動物性食品之衛生規則訂定這些規則。(7) The principal objective of the new general and specific hygiene rules is to ensure a high level of consumer protection with regard to food safety. (7) 新的一般和明確之衛生規則的主要目的是為了確保消費者關於食品安全之 高度保護。(8) An integrated approach is necessary to ensure food safety from the place of primary production up to and including placing on the market or export. Every food business operator along the food chain should ensure that food safety is not compromised. (8) 為了保護從初級生產的地方到包含產品上市或出口的食品安全，整合的方法是必須的。每個在食品鏈的業者應確保其不違及食品安全。(9) Community rules should not apply either to primary production for private domestic use, or to the domestic preparation, handling or storage of food for private domestic consumption. Moreover, they should apply only to undertakings, the concept of which implies a certain continuity of activities and a certain degree of organisation. (9) 歐盟區域法規不適用於國內私人使用，或供應國內私人使用之國內加工、處理或食品儲存。而且，其應只適用於具特定連續性的活動和一定程度組織的事業。(10) Food hazards present at the level of primary production should be identified and adequately controlled to ensure the achievement of the objectives of this Regulation. However, in the case of the direct supply of small quantities of primary products, by the food business operator producing them, to the final consumer or to a local retail establishment, it is appropriate to protect public health through national law, in particular because of the close relationship between the producer and the consumer. (10)存在於初級生產階段的食品危害應該被鑑定出並被適當的控制，以確保達成本規章的目標。然而，在初級產品少量直接供給的例子，由食品業者製造，到最終消費者或地方零售，由國家法律保護公共衛生是適當的；特別是因為製造者和消費者之間的關係密切。(11) The application of hazard analysis critical control point (HACCP) principles to primary production is not yet generally feasible. However, guides to good practice should encourage the use of appropriate hygiene practices at farm level. Where necessary, specific hygiene rules for primary production should supplement these guides. It is appropriate for the hygiene requirements applicable to primary production and associated operations to differ from those for other operations. (11)危害分析重要管控點(HACCP)的應用原則在初級生產業尚未普遍可行。不過，良好規範的指引應該鼓勵農場階段使用適當的衛生規範。必要時，初級生產的特定衛生規則應補充這些指引。適用於初級生產及相關業者的衛生要求不同於其他業者是適當的。(12) Food safety is a result of several factors: legislation should lay down minimum hygiene requirements; official controls should be in place to check food business operators compliance and food business operators should establish and operate food safety programmes and procedures based on the HACCP principles. (12)食品安全由許多因素所構成法令應該訂定最低的衛生要求、官方管制應檢查食品業者是否遵守法令規定？食品業者應該依HACCP原則建立及執行食品安全計畫和程序(13) Successful implementation of the procedures based on the HACCP principles will require the full cooperation and commitment of food business employees. To this end, employees should undergo training. The HACCP system is an instrument to help food business operators attain a higher standard of food safety. The HACCP system should not be regarded as a method of self-regulation and should not replace official controls. (13) 依HACCP的原則為基礎，程序的成功實施需要食品業者員工之全力合作和承諾。為此目的，員工應經過訓練。HACCP系統是幫助業者達成更高標準的食品安全，而不應被認為是自主管理的方法且不應取代官方管制。(14) While the requirement of establishing procedures based on the HACCP principles should not initially apply to primary production, the feasibility of its extension will be one element of the review that the Commission will carry out following implementation of this Regulation. It is, however, appropriate for Member States to encourage operators at the level of primary production to apply such principles as far as possible. (14) 雖然依HACCP原則建立之程序要求，不應一開始就使用於初級生產，其延伸的可行性將是審查的一個要件，委員會將完成接下來本規章的執行。然而，會員國鼓勵初級生產者盡可能去採用這樣的原則是適當的。(15) The HACCP requirements should take account of the principles contained in the Codex Alimentarius. They should provide sufficient flexibility to be applicable in all situations, including in small businesses. In particular, it is necessary to recognise that, in certain food businesses, it is not possible to identify critical control points and that, in some cases, good hygienic practices can replace the monitoring of critical control points. Similarly, the requirement of establishing critical limits does not imply that it is necessary to fix a numerical limit in every case. In addition, the requirement of retaining documents needs to be flexible in order to avoid undue burdens for very small businesses. (15) HACCP的要求應考慮國際法典中的原則。其應提供足夠的彈性以適用所有的情況，包括小型企業。尤其，必須了解在某些食品業裡，辨別危害管控點是不可能的，某些例子中，良好衛生規範可以取代危害管控點的監控。相同地，建立關鍵界限的要求並非指在每一例中需要固定一數量限制。除此之外，為了避免對很小的公司造成不合理的負擔，保留文件之要求需要有彈性。(16) Flexibility is also appropriate to enable the continued use of traditional methods at any of the stages of production, processing or distribution of food and in relation to structural requirements for establishments. Flexibility is particularly important for regions that are subject to special geographical constraints, including the outermost regions referred to in Article 299(2) of the Treaty. However, flexibility should not compromise food hygiene objectives. Moreover, since all food produced in accordance with the hygiene rules will be in free circulation throughout the Community, the procedure allowing Member States to exercise flexibility should be fully transparent. It should provide, where necessary to resolve disagreements, for discussion within the Standing Committee on the Food Chain and Animal Health established by Regulation (EC) No 178/2002. (16)彈性也適用於能夠繼續使用在任何生產、加工或食品分送階段以及廠場結構的傳統方法。彈性對於在特別限制中之區域特別的重要，尤其是地理受局限的地區，包括條約第299(2)條提到之最偏遠的地區。然而，彈性不應影響食品衛生的目標。而且，既然所有食品製造是依照衛生規則將在整個歐盟內自由流通，允許會員國採行彈性之作法程序應充分透明。依規章(EC) No 178/2002.，應該在食物鏈和動物衛生常務委員會討論中，提供解決歧見。(17) The setting of objectives such as pathogen reduction targets or performance standards may guide the implementation of hygiene rules. It is therefore necessary to provide procedures for that purpose. Such objectives would supplement existing food law, such as Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (1), which provides for the establishment of maximum tolerances for specific contaminants, and Regulation (EC) No 178/2002, which prohibits the placing on the market of unsafe food and provides a uniform basis for the use of the precautionary principle. (17) 設定例如病原菌降低或實施標準之目標，可以引導灌輸衛生法規的實施。為達該目的，應訂定程序。這樣的目標將補充現有的食品法律，像是1993年2月8日的執委會規章 No 315/93，製訂食品中污染物的聯盟處理程序、該法訂定特一污染物的最大容許量；規章(EC) No 178/2002禁止不安全的食品的上市，並提供統一的預防性的原則作業基礎。 (18) To take account of technical and scientific progress, close and effective cooperation should be ensured between the Commission and the Member States within the Standing Committee on the Food Chain and Animal Health. This Regulation takes account of international obligations laid down in the WTO Sanitary and Phytosanitary Agreement and the international food safety standards contained in the Codex Alimentarius. (18) 考量技術和科學的發展，委員會和食物鏈與動物衛生常務委員會內的會員之間，應該確保緊密和有效的合作。本法規考慮在WTO 衛生和植物衛生協議內制訂之國際義務和國際法典的食品安全標準。(19) The registration of establishments and the cooperation of food business operators are necessary to allow the competent authorities to perform official controls efficiently. (19) 廠場的註冊與食品業者的合作是讓權責機關有效的執行官方管控所必需的。(20) The traceability of food and food ingredients along the food chain is an essential element in ensuring food safety. Regulation (EC) No 178/2002 contains rules to ensure the traceability of food and food ingredients and provides a procedure for the adoption of implementing rules to apply these principles in respect of specific sectors. (20)食品和食品成分於食物鏈之追溯性的要求為確保食品安全所必要的要素，規章(EC) No 178/2002包含確保食品和食品成分追溯性的規定，並依產業特性之不同，提供執行規定的程序。 (21) Food imported into the Community is to comply with the general requirements laid down in Regulation (EC) No 178/2002 or satisfy rules that are equivalent to Community rules. The present Regulation defines certain specific hygiene requirements for food imported into the Community. (21)食品進口到歐盟應符合規章(EC) No 178/2002擬定的一般要求或滿足相當於歐盟規章的要求。本規章定義進口到歐盟食品的特定衛生要求。(22) Food exported to third countries from the Community is to comply with the general requirements laid down in Regulation (EC) No 178/2002. The present Regulation defines certain specific hygiene requirements for food exported from the Community. (22) 從歐盟出口到第三國的食品需遵守規章(EC) No 178/2002訂定之一般要求。本規章明訂從歐盟出口之食品的特定衛生要求。 (23) Scientific advice should underpin Community legislation on food hygiene. To this end, the European Food Safety Authority should be consulted whenever necessary. (23) 科學建議應支持歐盟對食品衛生立法。為此目的，歐洲食品安全局(EFSA)於必要時應進行協商事宜。(24) Since this Regulation replaces Directive 93/43/EEC, the latter should be repealed. (24)因本規章取代指令93/43 /EEC，後者將予以廢止。 (25) The requirements of this Regulation should not apply until all parts of the new legislation on food hygiene have entered into force. It is also appropriate to provide for at least 18 months to elapse between entry into force and the application of the new rules, to allow the affected industries time to adapt. (25) 此規章的要求應於食品衛生的新法生效時實施，而且應該有至少18個月的緩衝期，在正式使用新的法規前，讓食品業者有一段適應期。 (26) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (1), (26)施行此規章之必要措施應符合1999年6月28日制定之歐盟法令1999/468/EC擬訂的程序，經執行委員會授權執行。HAVE ADOPTED THIS REGULATION: 二、目錄Regulation (EC) No 852/2004如下第I章 總則第1條 適用範圍第2條 名詞定義第II章 食品業者之義務第3條 義務第4條 衛生要求第5條 危害分析重要管制點第6條 官方管制、認證與核可第III章 良好作業指引第7條 指引之發展、宣導及使用第8條 國家指引第9條 歐盟指引第IV章 進口與出口第10條 進口第11條 出口第V章 附則第12條 執行措施與過渡期之安排第13條 附件I與II之修正與改編第14條 執委會程序第15條 歐洲食品安全局(EFSA)之諮詢第16條 向歐洲議會與執委會報告第17條 廢止第18條 生效日附件I初級生產附件II食品業者一般衛生要求(附件I適用者除外)CHAPTER I第I章GENERAL PROVISIONS總則Article 1第1條Scope適用範圍1. This Regulation lays down general rules for food business operators on the hygiene of foodstuffs, taking particular account of the following principles: 1. 本法規訂定食品業者需遵守的食品衛生規範，其說明如下：(a) primary responsibility for food safety rests with the food business operator; (a)食品安全之基本責任歸屬於食品業者；(b) it is necessary to ensure food safety throughout the food chain, starting with primary production; (b)自初級生產開始，應確保整個食物鏈之食品安全； (c) it is important, for food that cannot be stored safely at ambient temperatures, particularly frozen food, to maintain the cold chain; (c) 室溫下無法安全儲存之食品(尤其是冷凍食品)，應保持於冷藏鏈(cold chain)中。(d) general implementation of procedures based on the HACCP principles, together with the application of good hygiene practice, should reinforce food business operators responsibility; (d)以HACCP原則作為一般執行之基本程序，搭配食品良好衛生規範(GHP)之落實應能強化食品業者之責任；(e) guides to good practice are a valuable instrument to aid food business operators at all levels of the food chain with compliance with food hygiene rules and with the application of the HACCP principles; (e) 良好規範指引，在食物鏈的各階層之食品業者遵循食品衛生法規與HACCP原則應用，是有價值的工具。(f) it is necessary to establish microbiological criteria and temperature control requirements based on a scientific risk assessment; (f) 依照科學危害評估之基礎，建立微生物標準與溫度管制要求是必須的。(g) it is necessary to ensure that imported foods are of at least the same hygiene standard as food produced in the Community, or are of an equivalent standard. (g) 確保進口食品與歐盟生產之產品衛生要求相同或等效。This Regulation shall apply to all stages of production, processing and distribution of food and to exports, and without prejudice to more specific requirements relating to food hygiene. 本法規應適用於所有階段的食品生產、加工、銷售與出口，並無損更詳細之食品衛生相關要求。2. This Regulation shall not apply to: 2. 本法規不適用於(a) primary production for private domestic use; (a) 國內私人使用之初級生產； (b) the domestic preparation, handling or storage of food for private domestic consumption; (b) 國內私人食用之國內食品預備、處理或儲存；(c) the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer; (c)由生產者直接供應少量之初級產品給最終消費者，或地方零售廠場直接供應給最終消費者； (d) collection centres and tanneries which fall within the definition of food business only because they handle raw material for the production of gelatin or collagen. (d) 採集中心與鞣皮廠在食品業者的定義內，因其負責動物膠或膠質之原料生產。3. Member States shall establish, under national law, rules governing the activities referred to in paragraph 2(c). Such national rules shall ensure the achievement of the objectives of this Regulation. 3. 會員國應依據國家法令建立本法第2段(c)所提及之作業程序。該國法令應確保達成本法規之目標。Article 2第2條Definitions名詞定義1. For the purposes of this Regulation:1.本法規用詞定義如下(a) food hygiene, hereinafter called hygiene, means the measures and conditions necessary to control hazards and to ensure fitness for human consumption of a foodstuff taking into account its intended use; (a) food hygiene食品衛生：以下稱之為衛生。係指控制食品危害與確保人類健康之必要措施與條件；(b) primary products means products of primary production including products of the soil, of stock farming, of hunting and fishing; (b) primary products初級產品：包括種植、養殖、狩獵以及漁撈等初級生產之產品； (c) establishment means any unit of a food business; (c) establishment 廠場：表示任何食品業者之單位； (d) competent authority means the central authority of a Member State competent to ensure compliance with the requirements of this Regulation or any other authority to which that central authority has delegated that competence; it shall also include, where appropriate, the corresponding authority of a third country; (d) competent authority 權責機關：係指會員國權責之中央機構確保遵從此法規或任何其他中央機構經授的權責機構。在適當時，也包括相符的第三國權責機構。(e) equivalent means, in respect of different systems, capable of meeting the same objectives;(e) equivalent 等效：係指不同的系統能達成相同的目標； (f) contamination means the presence or introduction of a hazard; (f) contamination污染：係指危害之存在或導入； (g) potable water means water meeting the minimum requirements laid down in Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (1); (g) potable water飲用水：係指符合1998年11月3日委員會指令 98/83/EC訂定之供人飲用的水; (h) clean seawater means natural, artificial or purified seaw